Brand Name | PORTEX® SPINAL ANESTHESIA TRAYS |
Type of Device | ANESTHESIA CONDUCTION KIT |
Manufacturer (Section D) |
SMITHS MEDICAL ASD, INC. |
6000 nathan lane north |
minneapolis MN 55442 |
|
Manufacturer (Section G) |
SMITHS MEDICAL NORTH AMERICA, |
10 bowman drive, |
|
keene NH 03431 |
|
Manufacturer Contact |
dave
halverson
|
6000 nathan lane n |
minneapolis, MN 55442
|
7633833310
|
|
MDR Report Key | 7514101 |
MDR Text Key | 108250496 |
Report Number | 3012307300-2018-01593 |
Device Sequence Number | 1 |
Product Code |
CAZ
|
UDI-Device Identifier | 15019517115710 |
UDI-Public | 15019517115710 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | E332605 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
other,user facility |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
05/14/2018 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Physician
|
Device Expiration Date | 10/01/2019 |
Device Catalogue Number | NEPI-NLD-15597C-20 |
Device Lot Number | 3566332 |
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
04/16/2018 |
Initial Date FDA Received | 05/15/2018 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 01/31/2018 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
|
|